NCT04321967

Nitropaste in Breast Reduction

Topical Nitroglycerin as a Mechanism for Cutaneous Vaso-modulation and Improved Wound Healing After Breast Reduction

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is evaluate the effect of Nitroglycerin paste on wound healing and scarring. Previous research has shown that Nitroglycerin paste can improve the blood flow to a wound, which may be associated with better wound healing, and ultimately, better scarring.

Detailed description

This will be a single-center, patient-blinded, (breast) randomized trial utilizing nitroglycerin paste on their breast reduction scar. The study team aims to randomize 100 patients, or 200 breasts. Each patient will receive treatment, but the breast that received treatment will be random. This will allow for a control breast to compare to. Patients will be followed for 12 months postoperatively to observe wound healing.

Conditions

• Gynecomastia
• Delayed Wound Healing

Interventions

Type	Name	Description
DRUG	Nitroglycerin Paste	1g of 2% Nitroglycerin paste topical application
DRUG	Dermabond	Topical skin adhesive

Timeline

• Start date: 2019-08-20
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2020-03-26
• Last updated: 2022-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study